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Onera STS 2 measures and records multiple physiological parameters from a patient during a sleep study, which are used by clinicians to decide on the diagnosis of sleep disorders.

Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson.

The recorded data will be made available to the healthcare professional to assist in the diagnosis of sleep disorders.

The device is intended to be used for adults.

The device is not a life supporting physiological monitor.

Onera Sleep Test System 2 (Onera STS 2) is a hardware, wearable system for measuring physiological signals during a sleep study. The device can be used in the home (Home Healthcare Environment) as well as in Professional Healthcare Facilities.

The device measures EEG, EOG, EMG, ECG, respiratory signals, cannula based respiratory flow, oxygen saturation, activity, position, ambient light level and sound pressure level.

The ECG signal is not intended for diagnosis of cardiac disorders, except for the manual determination of arrhythmia during polysomnography studies.

The Onera STS 2 does not provide any automated output like heart rate, assessments of arrhythmia, heart rate variability, or other related heart rate measurement functions.

Onera STS 2 consists of five Sensors applied on the forehead, upper chest area, abdomen and lower leg area (both left and right leg).

The Sensors should be placed on intact skin. During the night measurement it is not needed to inspect the application sites. The Sensors encrypt the recorded signals and upload the measurement data during the night to the Patient App installed on the patient's phone via Bluetooth. The Patient App securely transfers the data to the cloud interface for further processing once all data has been uploaded. The output of the system is represented by a file in EDF format which contains the recorded (physiological) signals. EDF files can be read by any application software that accepts such files as input.

It is not possible to relocate the Sensors during a sleep study since the Sensor is single-use and for one sleep study only.

Here's a summary of the acceptance criteria and study information for the Onera STS 2, based on the provided FDA 510(k) clearance letter:

Onera STS 2: Acceptance Criteria and Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on the SpO2 measurement accuracy as a key performance metric with specific acceptance criteria.

Note: While other parameters are listed as "Identical" to the predicate, specific numerical acceptance criteria for those parameters are not explicitly stated in this document beyond their qualitative equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 12 healthy subjects
  • 9 male, 3 female
  • Aged between 23 and 46 years old
• Data Provenance: The study was conducted in an "independent research laboratory." The country of origin is not explicitly stated in the provided text. The study involved "induced hypoxia," indicating a prospective, controlled experimental design.

3. Number and Qualifications of Experts for Ground Truth

• The document does not mention the use of experts to establish ground truth for the SpO2 accuracy test.
• The ground truth for SpO2 was established by "laboratory co-oximeter" measurements of arterial hemoglobin oxygen (SaO2) values from blood samples.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method. The SpO2 accuracy was determined by direct comparison of the device's SpO2 measurements to SaO2 values from a laboratory co-oximeter.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The device primarily measures physiological parameters, and the study focused on the accuracy of these measurements rather than human reader interpretation with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was conducted for SpO2 measurement accuracy. The device's SpO2 readings were directly compared to reference SaO2 values without human intervention in the SpO2 measurement process itself. The Onera STS 2 is described as measuring and recording parameters, with the output as an EDF file to be read by other software. The SpO2 accuracy assessment is specifically for the device's measurement capability.

7. Type of Ground Truth Used

• Objective Measurement (Laboratory Co-oximeter): For SpO2 accuracy, the ground truth was established by arterial hemoglobin oxygen (SaO2) values determined from blood samples using a laboratory co-oximeter, which is considered a gold standard for blood oxygen saturation.

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size for a training set. This is likely because the performance study described (SpO2 accuracy) is a validation of the device's sensor capabilities, not an evaluation of a machine learning algorithm that would typically require a training set. The device outputs raw physiological signals in EDF format for clinicians to interpret, rather than providing automated diagnoses based on an internal algorithm.

9. How the Ground Truth for the Training Set Was Established

• As no training set is mentioned or implied for the device's core functionality (measuring and recording parameters for clinician interpretation), this information is not applicable and not provided in the document.

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